Methohexital

FDA label, Par Health USA, LLC, intramuscular, effective 2026-05-05. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Boxed warning

WARNING BREVITAL should be used only in hospital or ambulatory care settings that provide for continuous monitoring of respiratory (e.g. pulse oximetry) and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation and personnel trained in their use and skilled in airway management should be assured. For deeply sedated patients, a designated individual other than the practitioner performing the procedure should be present to continuously monitor the patient. (See WARNINGS .)

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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Basis

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Preanesthetic medication is generally advisable. BREVITAL may be used with any of the recognized preanesthetic medications. Preparation of Solution FOLLOW DILUTION INSTRUCTIONS EXACTLY. Freshly prepare solutions of BREVITAL and use promptly. Reconstituted solutions of BREVITAL are chemically stable at room temperature for 24 hours.

Diluents ONLY USE BACTERIOSTATIC-FREE DILUENT – Recommended diluents are based on route of administration (see Dilution Instructions ). Incompatible diluents: Lactated Ringer’s Injection Dilution Instructions 1% solutions (10 mg/mL) should be prepared for intermittent intravenous and rectal administration; 0.2% solutions (2 mg/mL) should be prepared for continuous intravenous drug administration; 5% solutions (50 mg/mL) should be prepared for intramuscular administration.

Contents of vials should be diluted as follows: FOR INTERMITTENT INTRAVENOUS and RECTAL ADMINISTRATION The preferred diluent for intermittent intravenous and rectal administration is Sterile Water for Injection. 5% Dextrose Injection, or 0.9% Sodium Chloride Injection are also acceptable diluents. [See table below.] FOR CONTINUOUS INTRAVENOUS ADMINISTRATION For continuous drip anesthesia, prepare a 0.2% solution by adding 500 mg of BREVITAL Sodium to 250 mL of diluent.

For this dilution, either 5% glucose solution or isotonic (0.9%) sodium chloride solution ONLY is recommended as the diluent instead of sterile water for injection in order to avoid extreme hypotonicity. [See table below.] FOR INTRAMUSCULAR ADMINISTRATION The preferred diluent for intramuscular administration is Sterile Water for Injection. 0.9% Sodium Chloride Injection is also an acceptable diluent. [See table below.] Administration Dosage is highly individualized; the drug should be administered only by those completely familiar with its quantitative differences from other barbiturate anesthetics.

Adults BREVITAL is administered intravenously in a concentration of no higher than 1%. Higher concentrations markedly increase the incidence of muscular movements and irregularities in respiration and blood pressure. Induction of anesthesia For induction of anesthesia, a 1% solution is administered at a rate of about 1 mL/5 seconds.

Gaseous anesthetics and/or skeletal muscle relaxants may be administered concomitantly. The dose required for induction may range from 50 to 120 mg or more but averages about 70 mg. The usual dosage in adults ranges from 1 to 1.5 mg/kg. The induction dose usually provides anesthesia for 5 to 7 minutes. Maintenance of anesthesia Maintenance of anesthesia may be accomplished by intermittent injections of the 1% solution or, more easily, by continuous intravenous drip of a 0.2% solution.

Intermittent injections of about 20 to 40 mg (2 to 4 mL of a 1% solution) may be given as required, usually every 4 to 7 minutes. For continuous drip, the average rate of administration is about 3 mL of a 0.2% solution/minute (1 drop/second). The rate of flow must be individualized for each patient. For longer surgical procedures, gradual reduction in the rate of administration is recommended (see discussion of prolonged administration in WARNINGS ).

Other parenteral agents, usually narcotic analgesics, are ordinarily employed along with BREVITAL during longer procedures. Pediatric Patients BREVITAL is administered intramuscularly in a 5% concentration and administered rectally as a 1% solution. Induction of anesthesia For the induction of anesthesia by the intramuscular route of administration, the usual dose ranges from 6.6 to 10 mg/kg of the 5% concentration.

For rectal administration, the usual dose for induction is 25 mg/kg using the 1% solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Compatibility Information Solutions of BREVITAL should not be mixed in the same syringe or administered simultaneously during intravenous infusion through the same needle with acid solutions, such as atropine sulfate, metocurine iodide, and succinylcholine chloride.

Alteration of pH may cause free barbituric acid to be precipitated. Solubility of the soluble sodium salts of barbiturates, including BREVITAL, is maintained only at a relatively high (basic) pH. Because of numerous requests from anesthesiologists for information regarding the chemical compatibility of these mixtures, the following chart contains information obtained from compatibility studies in which a 1% solution of BREVITAL was mixed with therapeutic amounts of agents whose solutions have a low (acid) pH. [See table below.] Atropine Sulfate 1/100 gr 1 mL None Ppt Ppt Succinylcholine chloride 0.5 mg 4 mL None None Haze Succinylcholine chloride 1 mg 4 mL None None Haze Metocurine Iodide 0.5 mg 4 mL None None Ppt Metocurine Iodide 1 mg 4 mL None None Ppt Scopolamine Hydrobromide 1/120 gr 1 mL None None None Haze Tubocurarine chloride 3 mg 4 mL None Haze

StrengthAmount of Diluent to Be Added to the Contents of the BREVITAL VialFor 1% methohexital solution (10 mg/mL)
500 mg 50 mL no further dilution needed
StrengthAmount of Diluent to Be Added to the Contents of the BREVITAL VialFor 0.2% methohexital solution (2 mg/mL)
500 mg 15 mL add to 235 mL diluent for 250 mL total volume
StrengthAmount of Diluent to Be Added to the Contents of the BREVITAL VialFor 5% methohexital solution (50 mg/mL)
500 mg 10 mL no further dilution needed

Drug interactions

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Label text (1 paragraph)

Drug Interactions Prior chronic administration of barbiturates or phenytoin (e.g. for seizure disorder) appears to reduce the effectiveness of BREVITAL. Barbiturates may influence the metabolism of other concomitantly used drugs, such as phenytoin, halothane, anticoagulants, corticosteroids, ethyl alcohol, and propylene glycol-containing solutions.

Contraindications

CONTRAINDICATIONS BREVITAL is contraindicated in patients in whom general anesthesia is contraindicated, in those with latent or manifest porphyria, or in patients with a known hypersensitivity to barbiturates.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for methohexital. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, no adverse developmental effects were observed following administration of methohexital to pregnant rabbits and rats during organogenesis at doses up to 4 and 7 times the human dose respectively. Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours.

There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans [ See Data ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data Reproduction studies have been performed in rabbits and rats at doses up to 4 and 7 times the human dose respectively and have revealed no evidence of harm to the fetus due to methohexital sodium. In a published study in primates, administration of an anesthetic dose of ketamine for 24 hours on Gestation Day 122 increased neuronal apoptosis in the developing brain of the fetus. In other published studies, administration of either isoflurane or propofol for 5 hours on Gestation Day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring.

With respect to brain development, this time period corresponds to the third trimester of gestation in the human. The clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits. (See WARNINGS/Pediatric Neurotoxicity , PRECAUTIONS/Pediatric Use , and ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY ).

Lactation

Nursing Mothers Caution should be exercised when BREVITAL is administered to a nursing woman.

Breastfeeding (LactMed)

Amounts of methohexital in milk are very small. Existing data indicate that no waiting period is required before resuming breastfeeding after a single dose of methohexital. Breastfeeding can be resumed as soon as the mother has recovered sufficiently to nurse. When a combination of anesthetic agents is used for a procedure, follow the recommendations for the most problematic medication used during the procedure.

Alternatives LactMed suggests considering:
Source: LactMed: Methohexital (NICHD, public domain)Revised Dec 21, 2020

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